The U.S. Food and Drug Administration (FDA) accepted
Alimera Sciences Inc.
) re-submitted new drug application (NDA) for Iluvien. The FDA
said that the resubmission is a complete, class 2 response to the
complete response letter (CRL) issued by the agency in Oct 2013.
Alimera is looking to get Iluvien approved for the treatment of
diabetic macular edema (DME) in the U.S.
The Prescription Drug User Fee Act (PDUFA) date for Alimera
) Iluvien is now set for Sep 26, 2014.
We note that Alimera had suffered a setback in Oct 2013 when
it received the third CRL from the FDA. The FDA refused to
approve the NDA for Iluvien in its present form. The FDA stated
that the benefits of Iluvien did not outweigh its risks. In the
CRL, the FDA had indicated that results from a new study were
required to be submitted along with a minimum of 12 months of
follow-up for all enrolled patients. The FDA also talked about
deficiencies at the manufacturing facility for Iluvien.
Alimera resubmitted the NDA to the FDA in Mar 2014. Alimera
responded to the questions raised in the CRL. Alimera also
provided data from Iluvien patients in the U.K. and Germany.
Alimera in-licensed Iluvien from pSivida to develop it for
DME. The association between the two companies dates back to Feb
2005. Iluvien is marketed in U.K. and Germany. Moreover, the drug
is approved in Austria, France, Portugal and Spain. In Italy it
has been recommended for approval for the treatment of vision
impairment associated with chronic DME for patients considered
insufficiently responsive to available therapies. Alimera is also
seeking approval for the drug in 10 additional EU country
Once approved, pSivida will get a $25 million milestone
payment from Alimera along with 20% of net profits on U.S. sales
of Iluvien for DME.
pSivida currently carries a Zacks Rank #2 (Buy) while Alimera
carries a Zacks Rank #3 (Hold). Investors looking for
better-ranked stocks in the biopharma sector may consider
Sucampo Pharmaceuticals, Inc.
). Both carry a Zacks Rank #1 (Strong Buy).
ALIMERA SCIENCE (ALIM): Get Free Report
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PSIVIDA CORP (PSDV): Free Stock Analysis
SUCAMPO PHARMAC (SCMP): Free Stock Analysis
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